Date: 2011-08-16
Type of information:
phase: 2
Announcement: authorization of the trial
Company: Corimmune (Germany), Cluster m4 personalised medicine and targeted therapies (Germany)
Product: COR-1
Action
mechanism: In DCM patients, the presence of anti-ß1-receptor autoantibodies has been recognized as a negative prognostic marker correlating with more depressed left ventricular function, increased prevalence of serious ventricular arrhythmias, sudden cardiac death, and cardiovascular mortality.
Approximately 25-30 % of DCM patients and 10-15 % of ICM (idiopathic cardiomyopathy) patients present with such stimulatory anti-ß1-receptor autoantibodies, corresponding to 250,000 patients resident in Germany and 18 % of all patients with heart failure worldwide.
The COR-1 cyclopeptide is capable of neutralising anti-ß1 receptor autoantibodies. In animal models of cardiomyopathy, monthly intravenously administration of COR-1 significantly decreased anti-ß1-receptor autoantibody titres and improved cardiac function, as assessed both by invasive cardiac pressure measurements and echocardiography. In animal studies, COR-1 was at least as efficient in the treatment of heart failure as drugs of the current standard treatment regime, however, without the accompanying risk of hemodynamic decompensation (patent WO 002006103101A2).
In a phase I clinical trial, 50 male human volunteers received COR-1 doses ranging between 10-240 mg. All investigated doses were well tolerated in and no drug-related side effects occurred. Moreover, no anti-COR-1 autoantibodies were produced and favourable pharmacokinetic and pharmacodynamic profiles were observed.
Disease: heart failure, dilated cardiomyopathy (DCM)
Therapeutic area: Cardiovascular diseases
Country: Germany
Trial
details: This phase II clinical trial aims to investigate whether COR-1 treatment improves cardiac function in patients with dilated cardiomyopathy (DCM) and specific cardiac autoantibodies. The primary objective is to investigate whether intravenous COR-1 administration every 4 weeks in addition to standard therapy enhances cardiac function at rest in patients with heart failure due to DCM, compared to standard therapy alone after 6 months.
Secondary objectives aim to determine the efficacy and safety of COR-1 in DCM patients and characterise patient-specific factors that may predict COR-1 treatment success.
Primary completion of the study is expected in september 2013.
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